BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1800050 · Received August 16, 2010

    Report

    Report Number
    3005075853-2010-04638
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A BLUE CARTRIDGE RELOAD LOAD PRESENT. THE CARTRIDGE WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT AND ARTICULATED POSITIONS WITH TEST CARTRIDGE RELOADS AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS ARTICULATED AND DE-ARTICULATED AS INTENDED. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A LOCKED DEVICE A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. ONCE THE DEVICE IS OPENED THE DEVICE CAN BE DE-ARTICULATED. BATCH HISTORY REVIEW HAS BEEN COMPLETED WITH NO ANOMALIES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, THE DEVICE WAS INSERTED THROUGH THE TROCAR, ARTICULATED AND FIRED. THE SURGEON TRIED TO OPEN THE JAWS BUT THEY DIDN'T OPEN, HE PUSHED THE ANVIL RELEASE BUTTON BUT IT DIDN'T MOVE. THE SURGEON HAD TO WITHDRAW THE DEVICE WITH THE TROCAR AT ONCE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1